Most engagements run between two and five days of on-site or remote audit work, depending on the scope, the size of the facility, the number of product lines, and the regulations or standards in play. A focused single-standard gap assessment of one production line may fit comfortably into two days. A full multi-site, multi-standard audit covering both CFR and ISO requirements typically requires four to five days. Length is agreed up front during planning — we do not believe in scope creep or invoiced surprises.

JJCC Group conducts audits against 21 CFR Part 111 (dietary supplement CGMP), 21 CFR Part 117 (preventive controls for human food), 21 CFR Part 110 (legacy food CGMP), 21 CFR Parts 210 and 211 (pharmaceutical CGMP), and 21 CFR Part 820 (medical device quality system regulation). On the ISO side we audit against ISO 9001 for quality management systems, ISO 13485 for medical device QMS, and ISO 14971 for risk management of medical devices. We can audit against a single framework or against multiple frameworks in a combined engagement. 

An FDA mock audit is a simulated inspection conducted exactly as an FDA investigator would conduct it — same opening meeting structure, same document requests, same shop-floor walkthroughs, same questioning style, and a Form 483-style findings report at the close. JJCC Group leverages former industry quality leaders and regulatory professionals to expose vulnerabilities before a real inspection occurs. It is the single most effective way to pressure-test your readiness for an unannounced FDA visit and to give your QA team experience with the real cadence and posture of an inspection.  

A gap analysis is a structured comparison of your existing quality management system against the requirements of a specific standard, designed to identify which clauses or sections you already meet, partially meet, or do not meet. It is typically the starting point — and is often used before pursuing ISO certification or restructuring a QMS. A full audit goes further: it evaluates not just documented procedures but actual implementation, records, and effectiveness through interviews, observation, and evidence sampling. A gap analysis tells you where you are; an audit tells you where you really are.

Scope is finalized during planning, but typical areas include Quality Assurance and Quality Control, production and manufacturing, warehousing and material handling, sanitation and facility controls, document and records management, training, supplier and purchasing controls, complaint handling and CAPA, equipment qualification and calibration, laboratory operations, and management review. For medical device clients, design controls and risk management files are included. We can scope narrower and deeper, or broader and shallower, depending on your objectives and risk profile.

Preparation starts by aligning leadership on scope, naming a primary point of contact, and ensuring document and records owners are available during the audit window. Pull together the standard package — quality manual, SOPs, batch records, training records, CAPA log, complaint log, supplier qualifications, calibration records, and management review minutes. Brief your staff on what to expect, walk the shop floor in advance to address obvious housekeeping issues, and schedule key personnel to be on site. JJCC Group provides a tailored pre-audit checklist and document request list 7–10 days ahead of every engagement so nothing is left to chance. 

Yes. The audit report is the starting point, not the finish line. JJCC Group helps clients facilitate root cause analyses, write CAPA plans, rewrite or build out SOPs, design training programs, implement document control improvements, and conduct effectiveness checks. We can remain engaged through follow-up verification audits — typically conducted 60 to 120 days after remediation — until every finding is closed and your QMS is demonstrably back in compliance. Our goal is a quality system that holds up to a real inspection, not a clean report on a shelf. 

Yes. Our ISO accreditation readiness program is built around a gap analysis against the target standard — ISO 9001, ISO 13485, or ISO 14971 — followed by a remediation roadmap, QMS build-out or refinement, internal auditor training, a stage-1 readiness review, and a full mock certification audit before your registrar arrives. The objective is to walk into your stage-2 certification audit confident, not hopeful. Many clients sequence this over three to nine months depending on the maturity of their existing QMS.

Both. Document review, opening and closing meetings, and many interviews can be conducted remotely to reduce cost and travel time. Shop-floor observation, process verification, and physical walkthroughs are performed on-site. Most engagements adopt a hybrid model, with the on-site portion focused on what genuinely requires being there. For purely documentation-driven gap analyses, fully remote engagements are an option.

Every JJCC Group engagement begins with a mutual non-disclosure agreement. Audit findings, proprietary processes, formulations, customer lists, and any documents reviewed remain the property of the client and are never shared with third parties, used in marketing materials, or referenced in case studies without explicit written permission. Confidentiality is foundational to our practice and is treated accordingly.